FDA recall Z-0566-2018
Medtronic Sofamor Danek USA Inc · Class II · device
Product
Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only
Reason for recall
Medtronic has discovered the product lot in question was noted as having a longer drill tip extension than what is indicated on the print specification.
Distribution
MN, NC
Key facts
- Status
- Terminated
- Initiation date
- 2017-12-22
- Report date
- 2018-02-21
- Termination date
- 2018-07-31
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Memphis, TN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0566-2018